H2 Heated Humidifier
FDA 510(k) K030090 · Respironics, Inc.
510(k) numberK030090
Submission
- Device name
- H2 Heated Humidifier
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- January 10, 2003
- Decision date
- January 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
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| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
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Questions and answers
When was H2 Heated Humidifier cleared by the FDA?
H2 Heated Humidifier (K030090) received a 510(k) decision of Substantially Equivalent on January 24, 2003, 14 days after the submission was received.
What is the product code of K030090?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.